Science v. Ideology in Court: Mifepristone and the U.S. Food and Drug Administration
Authors: Wendy K. Mariner
Journal: Annals of Internal Medicine (2023)

Ideas and Opinions18 April 2023Science v. Ideology in Court: Mifepristone and the U.S. Food and Drug AdministrationFREEWendy K. Mariner, JD, LLM, MPHWendy K. Mariner, JD, LLM, MPHBoston University, Boston, Massachusetts (W.K.M.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M23-0981 SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Texas federal district court Judge Matthew J. Kacsmaryk's decision on 7 April 2023 to halt (stay pending further litigation) the nationwide marketing of mifepristone was disturbing for at least 3 reasons (1). If not reversed on appeal, it would end (or at least suspend pending further research) access to a safe and effective medication used for miscarriage and abortion since its 2000 approval by the U.S. Food and Drug Administration (FDA). Moreover, it used troubling judicial reasoning inconsistent with scientific evidence, legal precedent, and the rule of law. Finally, it raised the specter of similar challenges to other FDA-approved drugs by plaintiffs who simply object to their use.The CaseIn Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, the plaintiffs are medical groups and physicians who oppose abortion. They claimed that the FDA's original approval of mifepristone was arbitrary and capricious and therefore in violation of the Administrative Procedure Act, which governs internal procedures for many federal agencies. They did not, and could not, claim that FDA overstepped its statutory authority, because the FDA is charged by Congress with determining whether new drugs are safe and effective.Instead, the plaintiffs argued that mifepristone is not safe and should not have been approved at all. Accepting that claim would mean that a medication used safely and effectively by 5 million women over the past 23 years is too dangerous to remain on the market. In 2020, mifepristone was used in 53% of abortions, not to mention treatment of miscarriage (2). This would leave physicians and patients with misoprostol alone as an alternative, which is somewhat less effective and can cause more discomfort. In short, the decision makes abortion more difficult for women.The DecisionThe judge's responsibility was to determine whether the FDA had acted reasonably—not arbitrarily, capriciously, or politically—in approving mifepristone. Judges do not have the expertise to make medical or scientific decisions; that is not their job. They can only assess whether an agency has given fair consideration to all the evidence—pro and con—and explained the reasoning for its conclusion. This is where Judge Kaczmarek diverged from the judicial role.In the Alliance case, it is the judge's opinion that appears arbitrary, capricious, and partisan. The decision's tone departs from typical judicial evenhandedness, sounding almost scornful of the FDA and referring to physicians who provide reproductive care as “abortionists.” It uses tortured logic to give credence to the plaintiffs' claims and reject the FDA's arguments. The opinion concludes that mifepristone should never have been approved under subpart H of the Federal Food, Drug, and Cosmetic Act (“Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses” [3]) because pregnancy is not an illness, but rather “a normal physiological state most women experience.”The opinion also finds that the FDA's 2021 decision to allow mifepristone to be sent through the mail violates the Comstock Act of 1873. A series of statutes had made it a federal crime to distribute any obscene publication, including birth control information, or any article used for contraception or abortion (4). In 1971, after the U.S. Supreme Court found restrictions on contraception unconstitutional (5, 6), Congress amended the law to remove contraceptives from the list of forbidden articles. Comstock laws are now largely ignored, on the ground that they would not apply to any lawful product. The Alliance decision rejects that assumption.Most troubling, the opinion disregards the weight of scientific consensus and evidence. It suggests that “chemical abortion” is dangerous for women, ignoring higher risks from pregnancy and commonly used drugs like acetaminophen. It accepts the plaintiffs' speculative and sometimes misleading assertions that mifepristone and misoprostol do not provide a meaningful therapeutic benefit to patients over surgical abortion. Overall, the opinion seems to assume that the judge is free to substitute his own personal views for the FDA's expertise about what counts as a risk and a benefit and what evidence is credible. This is a disquieting departure from the judicial role of evaluating the FDA's decision-making process against the legal standard.Other DrugsIf anyone can challenge the FDA's approval of a drug or device they dislike, and if judges can make up facts to take it off the market, regardless of its safety and effectiveness, then developing any drug may be risky. Next may be misoprostol, contraceptives, preexposure prophylaxis for HIV infection, or COVID-19 vaccines. Pharmaceutical companies are alert to this risk. More than 400 biopharma and investment executives issued a statement condemning the Alliance decision, noting, “If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone” (7).What Next?The Alliance decision is not the final word. It is being appealed (8), and the appeals court panel allowed the drug to remain on the market pending court review but with pre-2016 Risk Evaluation and Mitigation Strategy (REMS) restrictions barring prescriptions via telemedicine, retail pharmacy dispensing, and use after 7 weeks of pregnancy (9). Also on appeal is a conflicting decision in a Washington federal district court maintaining the current availability of mifepristone in 17 states and the District of Columbia under the FDA's January 2023 REMS (10). The U.S. Supreme Court is being asked to resolve the conflict. If it refuses, whatever decisions the lower courts make will remain the law. If those decisions still conflict, nothing is resolved. If the Justices take the case, they could still avoid a decision on the merits by finding that the Alliance plaintiffs did not have legal grounds (standing) to bring their claims in the first place. That would be a reasonable legal conclusion, because the plaintiffs do not prescribe mifepristone, nor do they take it, and they have no cognizable injury from its availability. However, if the appeals support any of Judge Kacsmaryk's reasoning, it will be another step toward ending reproductive rights for women.ConclusionThe Alliance decision may encourage judges to impose their own views of what federal agencies should and should not decide, instead of how their decisions are made. It also heightens political tensions. It supports the post-Dobbs prediction that prolife advocates would not stop at restricting abortion but aim for a complete ban on abortion and possibly contraceptives. The medical profession has a strong interest in keeping politics out of scientific decision making. Physicians should be mindful that attacks on reproductive rights are almost always enforced by punishing physicians. Laws have never stopped women from trying to control pregnancy or seeking abortion. The only question is whether abortion is safe and available to all in need. Safety decisions should remain in the hands of physicians and scientists.References1. Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, 2023 U.S Dist. LEXIS 61474 (N.D. Tex, Amarillo Div., Apr. 7, 2023). Google Scholar2. Jones, Nash E, Cross L, et al. Medication abortion now accounts for more than half of all US abortions. Guttmacher Institute; 24 February 2022. Accessed at www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions on 13 April 2023. Google Scholar3. 21 C.F.R. § 314.520. Google Scholar4. 18 U.S.C. chapter 71, §§ 1460-1470. Google Scholar5. Griswold v. Connecticut, 381 U.S. 479 (1965). Google Scholar6. Eisenstadt v. Baird, 405 U.S. 438 (1972). Google Scholar7. Suliman S, Banks A, Levin J, et al. In Support of FDA's Authority to Regulate Medicines [Letter]. Accessed at https://docsend.com/view/2ahvmwy8djzxax3g on 13 April 2023. Google Scholar8. Stein P, Marimow AE, Kitchener C. Justice Department appeals Texas abortion pill ruling. The Washington Post. 10 April 2023. Google Scholar9. Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, No. 23-10362 (5th Cir., Apr. 12, 2023). Accessed at https://storage.courtlistener.com/recap/gov.uscourts.ca5.213145/gov.uscourts.ca5.213145.183.2_1.pdf on 13 April 2023. Google Scholar10. Washington v. U.S. Food and Drug Administration, 2023 U.S. Dist. LEXIS 61776 (E.D. Wash., Apr. 7, 2023). Google Scholar Comments0 CommentsSign In to Submit A Comment Author, Article, and Disclosure InformationAuthors: Wendy K. Mariner, JD, LLM, MPHAffiliations: Boston University, Boston, Massachusetts (W.K.M.)Disclosures: The author has reported no disclosures of interest. The form can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M23-0981.Corresponding Author: Wendy K. Mariner, JD, LLM, MPH, Boston University, 715 Albany Street, Boston, MA 02118; e-mail, [email protected]edu.Author Contributions: Conception and design: W.K. Mariner.Analysis and interpretation of the data: W.K. Mariner.Drafting of the article: W.K. Mariner.Critical revision for important intellectual content: W.K. Mariner.Final approval of the article: W.K. Mariner.Administrative, technical, or logistic support: W.K. Mariner.Collection and assembly of data: W.K. Mariner.This article was published at Annals.org on 18 April 2023. Previousarticle Advertisement FiguresReferencesRelatedDetails Metrics LatestKeywordsDrugsFood and Drug AdministrationMedical lawMiscarriagePregnancySafetyTermination of pregnancy ePublished: 18 April 2023 Copyright & PermissionsCopyright © 2023 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...